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510(k) K053580

DOCTOR'S NIGHTGUARD by Dental Concepts, LLC — Product Code MQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 2006
Date Received
December 22, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mouthguard, Prescription
Device Class
Class U
Regulation Number
Review Panel
DE
Submission Type

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